Device for Photoactivation and Reaction Monitoring
20170274218 · 2017-09-28
Inventors
- Andreas SCHMOCKER (Lausanne, CH)
- Christophe Moser (Lausanne, CH)
- Dominique Pioletti (Buchillon, CH)
- Pierre-Etienne Bourban (Nyon, CH)
Cpc classification
A61B2017/00411
HUMAN NECESSITIES
A61N5/062
HUMAN NECESSITIES
A61B2017/00632
HUMAN NECESSITIES
A61B17/0057
HUMAN NECESSITIES
A61B2017/005
HUMAN NECESSITIES
International classification
Abstract
The present invention relates to a device to photocure and/or photoactivate a photosensitive material. The device comprises several subsystems to transmit light towards an area of interest where a photosensitive material is applied as well as to collect light reflected by the applied photosensitive material. Reflected light is analyzed by an optical detector to monitor the photocuring and/or photoactivation process. Further means to inject or otherwise apply a photosensitive material can be combined in the same device. Methods for applying a fluent polymerizable material to a target site and for effecting polymerization of the fluent light-sensitive material in situ are also disclosed.
Claims
1-19. (canceled)
20. An optical device for at least one of photopolymerizing and activating of a photosensitive material, and for at least one of monitoring and controlling the at least one of photopolymerizing and activating, the optical device comprising: an actinic light source; and an analysis system operatively coupled to the actinic light source, wherein the analysis system is configured to analyze light coming from the photosensitive material to determine a degree of photopolymerization or activation of the photosensitive material during a photoactivation process.
21. The optical device according to claim 20, wherein the analysis system includes: a tubular applicator having a proximal end and a distal end, and an elongated shaft therebetween, the tubular applicator including a light transmitting element configured to bidirectionally transmit light between the proximal end and the distal end, the proximal end being operably connected to the actinic light source, and the distal end of the applicator being configured to emit the actinic light originated from the actinic light source to the photosensitive material and to capture light reflected or emitted by the photosensitive material; and a light guiding element which directs light travelling from the distal end through the light transmitting element towards an optical detector, the optical detector configured to detect the light reflected or emitted by the photosensitive material.
22. The optical device according to claim 21, wherein the light transmitting element includes an optical fiber.
23. The optical device according to claim 21, wherein the light guiding element includes at least one of a beam splitter, band pass filter, and Bragg grating.
24. The optical device according to claim 21, wherein the photosensitive material includes at least one of an implant, a filler, a tissue replacement, and gel or scaffold applied to a living host.
25. The optical device according to claim 21, wherein the actinic light source is configured to emit light in a wavelength range between 200 nm and 3000 nm.
26. A system comprising the optical device according to claim 21 and a device for injecting the photosensitive material.
27. The system according to claim 26, wherein a portion of the device for injecting the photosensitive material is contained within the tubular applicator.
28. The system according to claim 27, wherein the tubular applicator further includes a wall, a lumen, and an interspace between the light transmitting element and an internal side of the wall of the tubular applicator, wherein the interspace is configured to deliver a photocurable fluid material through the distal end of the tubular applicator.
29. The system according to claim 28, wherein the interspace coaxially surrounds the light transmitting element.
30. The system according to claim 28, further comprising: a subsystem to introduce one or more fluids to the interspace between the light transmitting element and the wall of the tubular applicator at or close to the proximal end of the tubular applicator, the one or more fluids forming a photocurable fluid after being mixed.
31. The system according to claim 26, wherein the tubular applicator includes at least one of a needle, a cannula, a catheter, and an endoscopic arm.
32. The system according to claim 26, further comprising: a mechanical element arranged on the tubular applicator, wherein the mechanical element includes at least one of a balloon, a cone-like element, a semi-sphere-like element, and hollow element, that is configured to artificially create a cavity in which a liquid material is pressurized.
33. The system according to claim 32, further comprising: an element configured to press the tubular applicator against a surface in a controlled manner to create a cavity in which the liquid material is pressurized.
34. A method of applying, photocuring, and monitoring a material into or onto a surface or a cavity, the method comprising the steps of: applying an initially entirely fluent, pre-polymeric photocurable material to the surface or the cavity through release from a distal end of an applicator; applying an actinic light from an actinic light source through a light transmitting element to the photocurable material for a time period to convert the entirely fluent, pre-polymeric photocurable material to a polymeric, non-fluent material, the polymeric, non-fluent material being in an amount effective to cover at least a portion of a target surface or a target cavity, the light transmitting element capturing light reflected or emitted by the photocurable material and delivering the reflected or emitted light to a light guiding element that directs light travelling from a distal end of the light guiding element towards an optical detector; detecting by the optical detector the light reflected or emitted by the photocurable material; and monitoring a curing process established by the step of applying the actinic light, including analyzing a change of a property of the light reflected or emitted by the photocurable material and detected by the optical detector, the change being a direct indication of the photocuring process itself.
35. The method according to claim 34, wherein in the step of applying the initially entirely fluent, pre-polymeric photocurable material, the initially entirely fluent, pre-polymeric photocurable material is applied into or onto the surface or the cavity at a certain pressure, in the step of applying the actinic light, directly bonds to the surface or the cavity are established, creating a high adherence between the polymeric, non-fluent material and the surface or the cavity.
36. The method according to claim 35, wherein the surface or the cavity is an animal body tissue or a body cavity.
37. The method according to claim 36, further comprising the step of: introducing the applicator inside the animal body through a surgical device or through an orifice.
38. The method according to claim 34, used for treatment or prevention of a pathological condition or cosmetic procedures such as complete or partial replacement of an organ such as part of the intervertebral disc; replacement, healing or strengthening of cartilage tissues such as the articular cartilage of any joints or non-hyaline cartilage; or injection and hardening of dental cement or hydrogels/composite hydrogels, treatment or filling of an aneurysms, in cosmetic and esthetic surgery procedures such as augmentation mammoplasty or a treatment of glabellar lines.
39. The optical device according to claim 21, wherein the actinic light source is configured to emit light in a wavelength range between 315 nm and 700 nm.
Description
BRIEF DESCRIPTION OF THE FIGURES
[0031]
[0032]
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
DETAILED DESCRIPTION OF THE INVENTION
[0039] The present disclosure may be more readily understood by reference to the following detailed description presented in connection with the accompanying drawing figures, which form a part of this disclosure. It is to be understood that this disclosure is not limited to the specific conditions or parameters described and/or shown herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed disclosure.
[0040]
[0041] The applicator 105 has an elongated shape with a proximal end and a distal end. In the frame of the present disclosure, the word “applicator” refers to any tool or device used to apply an actinic light directly into or onto an area of interest. In at least some aspects, the applicator is a tubular element comprising at least one light-transmitting element such as for instance optical fibers. In one embodiment, the applicator consists of one or more light-transmitting elements which are designed to supply actinic light to the distal end of the applicator and to transmit returning light. In an alternative embodiment of the invention, the applicator has a body, connecting the proximal and distal ends, defining a lumen which contains the light-transmitting elements. The term “distal” refers to a direction toward the end of the device near where the light interacts with the photosensitive material; the term “proximal” refers to the opposite direction, that is, toward the optical detection and data analysis system. The body typically has a length between 0.5 and 500 cm. The body typically has a wall, which is usually made of a biocompatible and resilient metal. The wall is typically constructed from nitinol or stainless steel. In some embodiments, the applicator wall may be a commercially available syringe needle, catheter or a cannula. In yet another embodiment, the applicator may be an endoscope. In some embodiments, the distal end of the applicator may contain a needle. The light-transmitting elements contained in the applicator according to this embodiment of the invention may fill the entire lumen of the body of the applicator, or they may be bound to the wall with adhesive or fasteners or may be touching the wall or may be displaced axially from the wall with spacers, typically made from a resilient polymer. In some particular embodiments, the body of the applicator consists of a catheter or any suitable tubular element having a shape adaptable to the area within which it is inserted, such as for instance a blood vessel. An applicator according to this aspect of the invention may be of various size and shape, typically has a tubular shape, and is constructed of a soft, flexible, biocompatible material.
[0042] The system for illumination 103 of the subsystem 113 may comprise any known light sources capable of producing light with the desired temporal and frequency characteristics. System for illumination 103 may be, for example, solid-state lasers, gas lasers, dye lasers, or semiconductor lasers. System for illumination 103 may also be LED or other broadband sources, provided that the light sources are sufficiently powerful to drive the photocuring process. In some instances, the system for illumination 103 inherently provide short pulses of light at the desired frequency.
[0043]
[0044]
[0045] Due to parallel photorheology measurements, spectral analysis allows to link chemical changes in the material to mechanical parameters thereof, thus avoiding the analysis of the mechanical properties in situ by other means such as indentation. In addition, the spectral signature or the amount of backscattered light also gives information about the position or the environment of the distal tip for instance indicate if a thick tissue segment is blocking the exiting light and thus position of the distal end has to be adjusted.
[0046] In one embodiment, the light-transmitting element consists of several optical fibers. For example, one or several optical fibers 509 can be consecrated to illumination and one or several optical fibers 508 are used to collect the light. In at least some aspects, the optical fibers of the applicator can be arranged in several ways. For instance, fibers transmitting several or certain specific wavelenghts can be envisaged or fibers of different sizes can be assembled to guide the light to the distal end of the applicator and guide it back. In a particular embodiment depicted in
[0047] In one embodiment, 501 consists of several light sources, of which at least one provides the actinic light to photopolymerize the injected material and at least one provides actinic light at a different wavelength to record the state of the reaction.
[0048]
F=f(t)
t being the time. By experimental tests a critical value F.sub.c is found. Once this threshold is reached, the user interface emits a signal which indicates that the photopolymerization or chemical reaction has reached a certain degree or is completed. In addition, the information of several peaks or shifts can be evaluated at the same time to increase the precision of the monitoring for instance using reflected light around 750 nm to gather information about the reaction state of material further away from the distal end while using reflected light around 550 nm to access the reaction state closer to the distal end, thus:
F.sub.i=f.sub.i(t)
Or
[0049]
t=f.sub.i.sup.−1(F.sub.i)
i being the indices of one peak. And different functions f.sub.i and thresholds F.sub.c,i can indicate different states of the reaction e.g.:
F.sub.c,1=F.sub.1=f.sub.1(t.sub.1)
F.sub.c,2=F.sub.2=f.sub.2(t.sub.2)
[0050] If F.sub.1 reaches the critical value F.sub.c,1 a signal is emitted, in this case at t.sub.1. If F.sub.2 reaches the critical value F.sub.c,2 a second signal is emitted, in this case at t.sub.2. The procedure is further illustrated in
[0051] This evaluation technique is based on fixing F.sub.c,i experimentally. The obtained plot can be subsequently combined with previously performed photorheology measurements. Photorheology measures the elastic modulus (G) of a material in function (g) of the time and total intensity of the light illumination (I):
G=g(t, I)
[0052] Thus, by combining the spectroscopy data (F,f) and the photo rheology data (G,g), the mechanical properties are evaluated online by:
F=f(g.sup.−1(G, I))
or
G=g(f.sup.−1(F),I)
[0053] Furthermore, by testing layers of different thicknesses F can be correlated to an elastic modulus at a certain depth (G.sub.d), thus indicating the state of polymerization at a given distance (d) of the probe:
G.sub.d=g.sub.d(f.sup.−1(F), I)
[0054] The procedure can be further generalized and applied to several peaks (indexed with i):
G.sub.d,i=g.sub.d,i(f.sub.i.sup.−1(F.sub.i), I)
[0055] For example by tacking the changes of peak #1 the elastic modulus at a distance of the tip d0 (which could be for example 5 mm) is deduced:
G.sub.d0,1=g.sub.d0,1(f.sub.1.sup.−1(F.sub.1),I)
[0056] Materials layers of serveal thickness (or at several depth) can be evaluated (
[0057] In case of a tissue layer blocking the exiting light the intensity
[0058] Finally, several peaks F.sub.1 and F.sub.2 can be compared and a critical value F.sub.C can be calculated for instance by dividing them (F.sub.C=F.sub.1/F.sub.2) or performing any other type of mathematical calculation.
[0059]
[0060] The various channels of the injection subsystem may be stabilized within a housing that may be made essentially of a solid inert material and may comprise a holder to hold the device ergonomically during its use, such as for instance during surgery procedures. The light delivered by the light transmitting elements 205 is transmitted in both directions (dotted arrow), illuminating the injected material and back-propagating the light reflected or emitted by the illuminated material. Guiding elements 206 permit to align the light transmitting elements in the device while avoiding the block of the fluid flow (for example by not surrounding it completely in the radial plain).
[0061]
[0062] In a particular embodiment, the device according to the present disclosure comprises a back-flow locking system, as shown in
[0063]
[0064] In at least some embodiments, the photocurable material can therefore be a filling material such as a natural or synthetic material for strengthening, replacing, healing, reinforcing or otherwise treating living tissues such us bones. Suitable filling materials include glues, epoxies, adhesives, cements, hard tissue replacement polymers, biodegradable polymers and copolymers, and various other biomaterials known in the art for strengthening, replacing or reinforcing tissue. As inert materials, bone reinforcing mixtures may be incorporated into surrounding tissue or gradually replaced by original tissue. In some embodiments, the photocurable material may be a filling material such as composite hydrogels for strengthening, replacing, healing, reinforcing or otherwise treating a nucleus pulposus of an intervertebral disc such as for example methacrylate and poly(ethylene-glycol) based polymers in combination with a photoinitiator and possibly reinforced with fibers such as cellulose nanofibrils. Those skilled in the art will recognize that numerous variants of the above mentioned materials known in the art are within the scope of the presently disclosed embodiments.
[0065]